Qualification and requalification services

With over 20 years of experience in the sector, QSGroup offers validation and qualification services in the pharmaceutical sector.  

Thanks to continuous training, in-depth studies and long-standing relationships with some of the most important companies on the international market, we have a deep knowledge of cGMP, FDA, GAMP, ISO and ANNEX regulations.  

We can assist with the validation of tools and equipment used in pharmaceutical, biotechnological and chemical processes as well as. Furthermore, we have an in-depth knowledge of the advanced therapy and research sector.  

We have a division dedicated exclusively to specialized GAP Analysis, Risk Analysis and specific consulting services for monitoring systems within the areas classified according to ISO 14644. 

After founding our ISO 17025-4:2018 certified Altiorlab laboratory, we are also able to help companies with requests related to this standard. 

Our specialized services

With over 20 years of experience in monitoring systems, we can offer high value services for our customers’ monitoring systems, including:

Ideation and implementation IQ/OQ/PQ protocols in cleanrooms and on GMP variable monitoring systems (particle, microbiological, t°/RH/Δp, O2, specific parameters), HVAC systems, isolators, glove boxes, hoods, pass boxes, autoclaves as well as transfer systems.

• Ideation and implementation IQ/OQ/PQ protocols in cleanrooms and on GMP variable monitoring systems (particle, microbiological, t°/RH/Δp, O2, specific parameters), HVAC systems, isolators, glove boxes, hoods, pass boxes, autoclaves as well as transfer systems
• TOC metrological chain control with NIST samples for SCADA
• Smoke study services
• Validation
• HEPA/ULPA absolute filter integrity test
• TOC qualification and requalification with specific protocols for data integrity
• Thermo Hygrometric mapping of warehouses, climatic cells and refrigerators
• Qualification and requalification of portable OPC meters with specific protocols for data integrity
• Evaluation of particle contamination classes (At rest and In operation)
• Qualification and requalification of HVAC systems: check instrument calibrations, air speed control, differential pressure check, filter integrity check
• Verification of compliance with 21 CFR, part 11
• Preparation of Impact assessments, Gap analysis and Risk analysis
• Calibration of instruments on-site with our mobile laboratory
• Calibration and certification of potentiometric, KF, volumetric and coulometric holders
• Calibrations and certifications of pHmeters, laboratory conductivity meters, scales, thermostatic baths, melting point and stoves
• Calibration of reference instrumentation in our accredited laboratory (LAT Center n.266).

How we work

We believe that there are 7 points to achieve a perfect clean room:

1. As-built analysis of the particle monitoring system in the departments involved (FMS Sample Line Configuration)
2. As-built identification of representative sampling points with worst case identification, verification of particle probe geometry, study of particle decay in the pipeline 
3. Qualification and upgrading study, verification that the system as a whole meets the efficiency requirements to be used according to the standards
4. Document listing the laboratory results and improvement recommendations, Validation Summary
5. Field application of what described in point 4
6. ISO 21501-4:2018 calibration of meters on mobile laboratory ISO 17025:2018 at the customer’s workplace
7. Flow Switch, QE and LSAPC Maintenance of FMS, data integrity compliance analysis (ISO 21 CFR – 11).